FDA.reportPublic FDA data

PMA P150031S044

Device
Vercise Genus™ Deep Brain Stimulation (DBS) System
Applicant
Boston Scientific Corp
PMA number
P150031
Supplement
S044
Product code
NHL
Decision date
2021-10-07
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Approval order statement
Update to the Implantable Pulse Generator (IPG) Automatic Test Equipment (ATE) software to widen the acceptance criteria limits during the (PCBA) manufacturing process.

Current openFDA PMA Record#

Device
Vercise Genus™ Deep Brain Stimulation (DBS) System
Applicant
Boston Scientific Corp
PMA number
P150031
Supplement
S044
Product code
NHL
Generic name
Stimulator, electrical, implanted, for parkinsonian symptoms
Decision date
2021-10-07
Decision code
OK30
Date received
2021-09-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update to the Implantable Pulse Generator (IPG) Automatic Test Equipment (ATE) software to widen the acceptance criteria limits during the (PCBA) manufacturing process.